Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
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Purpose
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic hepatitis C, who failed PEG-Intron plus Rebetol treatment in protocol P02370 (NCT00039871).
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C Liver Fibrosis |
Biological: peginterferon alfa-2b (SCH 54031) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PEG-Intron(TM) Maintenance Therapy vs. an Untreated Control Group for Prevention of Progression of Fibrosis in Adult Subjects With Chronic Hepatitis C With Hepatic Fibrosis (METAVIR Fibrosis Score of F2 or F3), Who Failed Therapy With PEG-Intron Plus REBETOL(R) (in Protocol No. P02370) |
- Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3). [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:
Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).
Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
- Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).
Changes in liver inflammation defined as follows:
Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
- Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.
Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis).
- The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:
Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).
Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
- Mean Change in the METAVIR Activity Score (Using a Continuous Scale) [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.
Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis).
- Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment. [ Time Frame: Baseline to up to Month-36 ] [ Designated as safety issue: No ]
Definitions:
Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).
Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.
No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.
Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline.
| Enrollment: | 540 |
| Study Start Date: | October 2002 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW)
PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
|
Biological: peginterferon alfa-2b (SCH 54031)
0.5 µg/kg Weekly QW SC for 36 months
|
| No Intervention: Untreated Control |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age at entry in study P02370 (NCT00039871) 18-65 years;
- Nonresponder to PEG-Intron plus Rebetol in study P02370
Exclusion Criteria:
- Participants who did not participate in the P02370 study.
- Any medical condition, including but not limited to decompensated liver disease, malignancy or substance abuse, that developed during the P02370 study which could interfere with the participant's participation in and completion of this study.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00049842 History of Changes |
| Other Study ID Numbers: | P02570 |
| Study First Received: | November 14, 2002 |
| Results First Received: | October 7, 2010 |
| Last Updated: | March 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fibrosis Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Liver Cirrhosis Hepatitis C, Chronic Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Peginterferon alfa-2b Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013